Cosmetic surgery encompasses a number of techniques and surgical procedures that focus on enhancing and improving the aesthetic appeal of one or more parts of the body. Beneficially, cosmetic surgical procedures may also provide a number of positive benefits for the overall health and well-being of a patient. While the terms plastic surgery and cosmetic surgery are often used interchangeably by patients, there are some important technical differences. While both cosmetic surgery and plastic surgery deal with improving a patient's body, the overarching training, background certification, and even goals for patient outcomes are not always the same. Particularly, plastic surgery is defined as a surgical specialty dedicated to reconstruction of facial and body defects due to birth disorders, trauma, burns, and disease. Plastic surgery intends to correct dysfunctional areas of the body to achieve a more “normal” function and appearance and is thus reconstructive in nature. On the other hand, the procedures, techniques, and principles of cosmetic surgery are mostly focused on enhancing a patient's appearance. Thus, the key goals for cosmetic surgery are to improving aesthetic appeal, symmetry, and proportion of areas of the human body. Further, cosmetic surgery is usually elective, because the treated areas are usually functioning properly.
Cosmetic surgery is a surgery specialty practiced by doctors from a variety of medical fields, including, but not limited to, plastic surgeons. To become well-versed in commonly sought cosmetic surgical procedures, additional training and exposure may be required by any physician, including a plastic surgeon. While some cosmetic surgical procedures are included in the plastic surgeon's medical residency program, it is highly recommended that anyone who is performing any cosmetic surgical procedure go above and beyond the minimum level of training to ensure they have experience in performing all cosmetic surgery procedures of the face, neck, breast, and body.
Despite the above clarification of some differences between plastic surgery and cosmetic surgery, it is noted that patients will often seek out either a plastic surgeon and/or a physician who specializes in cosmetic surgery based on their extensive training to enhance and improve the aesthetic appearance of one or more body parts of concern to the patient. For simplification of the present description, cosmetic surgery will be referred to throughout the remainder of the description as including certain elective, aesthetic enhancement surgical procedures that may be performed by any qualified, licensed physician, including cosmetic surgeons or plastic surgeons, but most preferably, by very experienced, highly trained physicians, including cosmetic surgeons and/or plastic surgeons, who focus on providing their medical services with the highest possible levels of patient care and patient safety.
Cosmetic surgery may be performed on all areas of the body, with the focus on enhancing and improving the aesthetic appearance, symmetry, and proportionality of these various parts of the human body. The scope of work included in cosmetic surgical procedures may relate to breast enhancement, facial surgery, body contouring, and/or skin rejuvenation. In terms of breast enhancement, cosmetic surgeons may be sought out by a patient to perform breast lifts, breast augmentation (to increase the size of the breast), or even breast reductions to reduce the size of overly large breasts. Additionally, cosmetic surgeons are well known for providing body contouring surgical procedures such as arm lift (brachioplasty), buttock enhancement, tummy tucks (abdominoplasty) and liposuction. Further, facial rejuvenation is frequently sought out by patients who may elect to undergo a facelift, facial implant and/or eyelid lift, neck lift, or brow lift to reduce the effects of age, such as sagging of the skin, wrinkles, and other side effects of ageing to one's face. Other commonly desired cosmetic surgical procedures may include facial contouring surgical procedures such as rhinoplasty, chin, or cheek enhancement.
It is important to note that these cosmetic surgical procedures require a great deal of skill and expertise on the part of a cosmetic surgeon who must train extensively for many years. Extensive training in cosmetic surgery and patient care is required not only so that the cosmetic surgeon can hone his or her skills in shaping and enhancing parts of the body, but also because there is a very real risk for any number of life-threatening conditions to develop by virtue of the nature of surgery itself and also as a result of the techniques used. For example, there is a serious risk of infection, excessive blood loss, respiratory complications, and/or cardiac arrest occurring while a patient undergoes one or more cosmetic surgical procedures. Therefore, it is important for a cosmetic surgeon to be very mindful and well-versed in all the proper measures to avoid and/or mitigate any such negative health conditions from developing during surgery. Over the years a number of techniques have been developed to ensure the safety and well-being of a patient undergoing a cosmetic surgical procedure, but complications do still arise, and it is important to remain vigilant of these risks.
Ultimately, cosmetic surgeons are aware that their patients seek them out to achieve aesthetic rejuvenation and to improve their physical appearance. In addition to the improvements in physical appearance, it is well-documented that additional positive side-effects to cosmetic surgery include 1) a vast improvement in how patients feel about themselves 2) increased opportunities in their personal and professional lives, and often 3) improved mental health. Further, while many of the above-mentioned procedures aim to improve the aesthetical appearance of a body part, there may also be a number of physical health benefits from the cosmetic surgical procedure as well. For example, rhinoplasty is a nose shaping surgery performed on a patient that reshapes the patient's nose to improve the overall shape, but also, has the added benefit of improving a patient's ability to breath from their nose. Likewise, after undergoing a breast reduction, a patient is relieved of a great deal of back and neck pain from the excess weight and size of the breasts, and also see an improvement in the symmetry of their overall body profile.
It is no wonder that over 15 million cosmetic surgical procedures have been performed in America alone in recent years. Patients are eager to improve their physical appearance, which is of critical importance. Nevertheless, for many, there does exist a great deal of anxiety associated with the thought of undergoing cosmetic surgery. Additionally, the prospect of being anesthetized and the possible risks and harmful after-effects of various forms of anesthesia, especially general anesthesia, also greatly contributes to the patient's anxiety.
Anesthesia enables the painless performance of medical procedures that would otherwise cause severe or intolerable pain. A patient who is under the effects of anesthetic drugs is referred to as being anesthetized. More specifically, in the practice of medicine, and especially surgery, anesthesia is a state of temporary induced loss of sensation or awareness. In some cases, anesthesia may include analgesia (relief from or prevention of pain), paralysis (muscle relaxation), amnesia (loss of memory), or unconsciousness, particularly when general anesthesia is used.
For purposes of simplification in the present description, a broad overview of several categories of anesthesia is provided. These categories include general anesthesia, epidural/spinal anesthesia, moderate sedation, monitored anesthesia care (MAC), regional anesthesia, and local anesthesia. General anesthesia is associated with a deep sedation, normally administered intravenously (IV) or inhaled. General anesthesia suppresses central nervous system activity and results in unconsciousness and total lack of sensation. Epidural and spinal anesthesia can be used for most surgeries below the belly button, and are frequently used for labor, cesareans, surgeries of the colon and gastrointestinal tract, gynecologic and urologic surgeries. Moderate sedation suppresses the central nervous system to a lesser degree, inhibiting both anxiety and the creation of long-term memories, without resulting in unconsciousness. Monitored anesthesia care (MAC) is the intravenous administration of mild sedatives to help a patient relax and to relieve anxiety during procedures that do not require general anesthesia.
Regional anesthesia and local anesthesia both block transmission of nerve impulses between a targeted part of the body and the central nervous system, causing loss of sensation in the targeted body part. A patient under regional or local anesthesia remains conscious, unless sedation is administered at the same time. Regional anesthesia involves administration of a regional block that is directed at the trunk of a nerve and affects all the branches of the nerve that comes from that trunk. Local anesthesia is injected in a particular area and blocks only where injected, not father down the branches of the nerve.
Traditionally, general anesthesia has been the preferred method by many surgeons for anesthetizing patients undergoing cosmetic surgery. There are both major and minor risks of anesthesia, but particularly so, for general anesthesia where a patient is put in a state of unconsciousness and paralysis. An extreme risk complication as a result of the medicines administered for general anesthesia includes mortality (i.e. death of a patient) and morbidity, which are diseases or disorders that develop as a result of the general anesthesia. For example, surgeons are always aware of the possibility of myocardial infarction (heart attack) and/or cardiac arrest, lung infections and/or pneumonia, pulmonary embolism, renal failure/insufficiency, as well as postoperative cognitive dysfunction occurring responsive to the general anesthesia and as a result of a disorder, a patient may have a severe change in blood pressure, excessive speeding up or slowing down of the heart rate, and also may develop in some rare cases, malignant hyperthermia, where the patient develops a dangerously high temperature that must be reversed.
The risk of deep vein thrombosis (DVT) occurring during cosmetic surgical procedures is always present, particularly in procedures such as face lifts, abdominoplasty (ex. tummy tuck surgery), and especially lower body surgery, and particularly so, when the patient spends longer periods being under general anesthesia. DVT is a condition where a blood clot forms in a deep vein in the body. Blood clots occur when blood thickens and clumps together. Most deep vein blood clots occur in the lower leg or thigh, but they can also occur in other parts of the body. A blood clot in a deep vein can break off and travel through the bloodstream. The loose clot is called an embolus, and it can travel to an artery in the lungs and block blood flow. This condition is called pulmonary embolism (PE), which is a very serious, life-threatening condition, as it can damage the lungs and other organs in the body and cause death.
Due to all these serious risks, only certified anesthesiologists are allowed to administer general anesthesia. Therefore, during cosmetic surgical procedures where the surgeon has determined to administer general anesthesia to a patient, a certified anesthesiologist is responsible for providing the correct dosages and drugs to induce deep sedation and unconsciousness and must be present the entire time the cosmetic surgical procedure is taking place in the operating room. Further, patients under general anesthesia must undergo continuous physiological monitoring to ensure safety in view of all of the risk of complications.
When a patient is under general anesthesia, the patient cannot reliably breathe on their own and also cannot respond to commands. Accordingly, to control breathing when under general anesthesia, patients are intubated and a breathing tube is inserted down the patient's windpipe. The patient must then be attached to a ventilator or other breathing device to ensure that the patient is breathing. The intubation process must be performed very carefully and requires skill to avoid tearing the vocal cords, damaging the airway, perforating the trachea, or accidentally passing the breathing tube through the esophagus and not the trachea, which means that the air is not being delivered to the lungs where it is needed. It is very common for patients to report a sore throat after waking up from general anesthesia due to the intubation, which is a potentially risky technique and requires great skill.
In addition to all of these major risks associated with general anesthesia, there are also what are known as minor risks that are not life-threatening, but that are no less uncomfortable for the patient. The negative side-effects of being under general anesthesia, and these minor risks, include postoperative nausea and vomiting and hospital readmission, as well as urinary retention and constipation, which may be particularly painful and uncomfortable after a patient has undergone a procedure such as a tummy tuck surgery. More common anesthesia risks include waking up confused and disoriented, and shivering. A less common complication is anesthesia awareness, or waking up in the middle of surgery.
Further, the use of an intravenous (IV) sedation during cosmetic surgery to administer anesthesia also presents a number of risks that should not be overlooked. The risks associated with the use of IV sedation during cosmetic surgery include respiratory depression, cardiac depression, stress to a patient from putting in an IV, infiltrated IV, thrombosis of the vein that the IV is located in, as well as thrombophlebitis to name a few of the major concerns. Therefore, the use of IV sedation in lieu of general anesthesia also presents a wide variety of potential complications and concerns that must be closely monitored during the surgical procedure.
Currently there are a number of solutions for surgery anesthesia. As noted above, cosmetic surgeons usually opt for general anesthesia so as to ensure that their patients are in a deep sedation and unlikely to wake up or feel pain. However, Dr. Jeffrey Klein, a dermatologic surgeon, based in Orange County, Calif., is credited with being the inventor of tumescent local anesthesia and tumescent liposuction, which uses local anesthesia during liposuction. Liposuction is the most commonly performed cosmetic procedure in the United States, and elsewhere. It is also referred to as liposculpture or lipoplasty, and is performed by cosmetic surgeons to reduce unwanted, fatty deposits on the body. Most commonly, liposuction is used on the abdomen, thighs, buttocks, neck, chin, upper and backs of the arms, calves, and back.
During liposuction, the fat is removed through a hollow instrument known as a cannula, which is inserted under the skin. A powerful, high-pressure vacuum, which acts as a suction device, is applied to the cannula. Through small incisions, the cannula is inserted into fatty areas between the skin and muscle where the cannula removes excess fat either using a suction pump or a syringe. The effects of liposuction are meant to include a smoother, improved body contour and permanent removal of fat from an area of the body.
In the past, liposuction required blood transfusions because blood loss found in the aspirate was so significant. Further, liposuction was most often performed while the patient was under general anesthesia and asleep. Dr. Jeffrey Klein is well-known for his development and use of tumescent liposuction, which has allowed liposuction to be performed using infiltration of large volumes of tumescent solution during liposuction. Since its inception, liposuction performed with the tumescent technique has had an excellent safety profile.
Tumescent liposuction is a specialized technique of performing liposuction that includes providing local anesthesia in the form of lidocaine mixed with a small amount of epinephrine to large volumes of subcutaneous fat, which thus permits liposuction. Lidocaine, also known as xylocaine and lignocaine, is a medication used to numb tissue in a specific area and can also be used as a local nerve block or local anesthetic. In the tumescent technique for liposuction surgery, large volumes of a diluted solution of lidocaine is mixed with a small amount of epinephrine. Tumescence refers to anything that is swollen and firm. and when used in surgery is a type of infiltration technique used to swell up the fat cells in the targeted area. During tumescent liposuction, the medical provider injects subcutaneously the special solution of salt solution, lidocaine, and epinephrine into the layer of fat. Relatively large volumes (ex. <4 L or more of the solution) are injected ahead of the cannula. The solution swells the fat cells making them easier to isolate and remove. The solution also shrinks blood vessels as a result of the epinephrine, which is a vasoconstrictor. The solution further helps to ease the patient's discomfort because it contains the local anesthesia (i.e. lidocaine) without the risks associated with the general anesthesia. The lidocaine solution is deposited exactly along the eventual pathway of the liposuction cannula that is used to break up and suck up fat from a part of the body.
As noted above, Dr. Klein's tumescent liposuction procedure is highly recognized as being an improved way of performing liposuction. Tumescent liposuction is known for offering several advantages. A primary benefit of the tumescent liposuction in view of traditional methods of performing liposuction is that there is significantly less blood loss that occurs during the fat suction procedure. Nevertheless, Dr. Klein is known for being conservative in terms of the amount of lidocaine recommended during the tumescent liposuction procedure. The traditional way of preforming tumescent liposuction using Dr. Klein's techniques involves a recommended upper limit of 35 milligram (mg) of lidocaine per kilogram (kg) of bodyweight using the diluted solution noted above. Notably, in U.S. Patent No. 2017/0100331, Dr. Klein recommends 28 mg/kg of lidocaine for infiltration of local anesthesia. This may be particularly to avoid significant risks associated with lidocaine toxicity. While generally safe, lidocaine toxicity can be a result of exceeding a maximum safe dosage and may result in circumoral numbness, facial tingling, restlessness, vertigo, tinnitus, slurred speech, and tonic-clonic seizures, and other symptoms of toxicity. Further, Dr. Klein may not recommend using higher concentrations of lidocaine, because he is also known for utilizing IV sedation in combination with the tumescent anesthesia. It is reported that the Klein method involves IV administration of anti-anxiety medications, such as diazepam, during his tumescent liposuction procedures, whereby he administers some form of sedation through an intravenous (IV) catheter filled with the diazepam and used to sedate the patient. Thus, the use of IV sedation is a common occurrence with conventional methods of tumescent anesthesia in cosmetic surgery, including when liposuction is performed, even though there are still many risks and potential problems that may arise because of the use of IV sedation (e.g. respiratory depression, cardiac depression, stress to a patient from putting in an IV, infiltrated IV, thrombosis of the vein that the IV is located in, as well as thrombophlebitis).
Of primary importance is the need to address a patient's anxiety and distress prior to and during a cosmetic surgical procedure. While there are some existing publications that describe combining anesthesia with other agents for various reasons, some of which may have an effect on the anxiety of the patient, these publications are still deficient for many reasons. For example, U.S. Pat. No. 6,921,541 describes a system and method of combination of an augmenting agent and an anesthetizing agent for inducing sustained regional local anesthesia in a patient to prolong the duration of the local anesthesia for a time period longer than that obtainable from the substrate without the augmenting agent. Further, U.S. Patent Publication No. 2009/0048237 (the '237 Publication) describes using oral medications comprising formulations effective for induction of procedural sedation and analgesia (the inability to feel pain), for example prior to induction of general anesthesia. The dosage forms comprise the combination of a drug typically used to treat anxiety, including a drug of the benzodiazepine class, such as triazolam, and an analgesic drug, such as sufentanil, delivered by the oral transmucosal route in a single dosage form. In the '237 Publication, the goal is to effect procedural sedation and analgesia using oral medication during or prior to general anesthesia. However, lacking from either of these patent publications is any utilization of tumescent anesthesia that may also have a number of positive benefits for a patient undergoing a cosmetic surgical procedure and thus fails to encompass a complete approach for maximizing a patient's comfort and reducing any pain or anxiety related to an operation.
There are many conventional pre-operation (pre-op) instructions given to a patient prior to undergoing a cosmetic surgical procedure, including many instructions that require a significant change in their routine starting from the day before the surgery is scheduled to occur. These sudden changes to a patient's routine contributes to the anxious psychological state of the patient prior to surgery. For example, most patients are instructed to fast and are forbidden from ingesting any food or drink (other than water) anywhere from 4-12 hours prior to having a surgical procedure performed. Further, to avoid any possible complication with anesthesia, particularly general anesthesia, patients may be prohibited from taking their regular medicines prior to surgery. When these changes in a patient's routine are compounded with the concerns regarding the risks of being anesthetized using general anesthesia, it is no wonder that a patient may not be in a calm state prior to surgery and may feel a high level of stress and anxiety.
Therefore, there currently exists a need in the industry for a process that allows for a more pleasant, comfortable experience for a patient undergoing one or more cosmetic surgical procedures.